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Pfizer Excludes EU Biosimilar Experience From US Epoetin Application

Executive Summary

Even though US product has same cell line and drug product formulation as EU-approved Retacrit, Hospira subsidiary did not bridge to it in its US biosimilar application, meaning US FDA could not consider EU safety and efficacy experience.

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Pending Biosimilars

Biosimilar applications using the 351(k) pathway under review at US FDA. Updated upon new submissions.

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